pre-sol-notice_illumina_final_1.docx

Pre-Solicitation Notice

Illumina Reagents and Consumables

Solicitation No. 75N92025Q00003

INTRODUCTION:

THIS IS A PRE-SOLICITATION NON-COMPETITIVE (NOTICE OF INTENT) SYNOPSIS TO AWARD A CONTRACT WITHOUT PROVIDING FOR FULL OR OPEN COMPETITION (INCLUDING BRAND-NAME).

THIS IS A SYNOPSIS. THIS IS NOT A SOLICITATION.

The National Heart, Lung, and Blood Institute (NHLBI), Office of Acquisitions (OA) on behalf of the National Human Genome Research Institute (NHGRI), intends to negotiate and award a contract without providing for full and open competition (including brand-name) to Illumina, Inc., for the requirement entitled “Illumina Reagents and Consumables”.

NORTH AMERICAN INDUSTRY CLASSIFICATION SYSTEM (NAICS) CODE:

The intended procurement is classified under NAICS code 334516 - Analytical Laboratory Instrument Manufacturing with a small business size standard of 1,000 employees.

REGULATORY AUTHORITY:

The resultant contract will include all applicable provisions and clauses in effect through the Federal Acquisition Circular (FAC) 2025-01 effective 11/12/2024. This acquisition is conducted under the procedures as prescribed in FAR subpart 12—Acquisition of Commercial Items and FAR subpart 15—Contracting by Negotiation at an amount exceeding the simplified acquisition threshold (SAT).

STATUTORY AUTHORITY:

This acquisition is conducted under the authority of 41 U.S.C. 253(c) under provisions of the statutory authority of FAR Subpart 6.302-1—Only one responsible source and no other supplies or services will satisfy agency requirements 41 U.S.C. 253(c)(1).

DESCRIPTION OF REQUIREMENT:

Background:

The NIH Intramural Sequencing Center (NISC) is a centralized research facility for performing high- throughput, large-scale DNA sequencing and sequence analysis. The NIH and NISC have numerous Illumina Nova Seq X plus, Systems, NextSeq 1000/2000 Systems, MiSeq Systems, MiniSeq Systems, iSeq Systems, and iScan Systems. These are proven platforms for genetic analysis and functional genomics. Illumina’s highly parallel sequencing technology leverages clonal cluster formation and proprietary reversible terminator chemistry to give it the speed and low cost of large-scale sequencing to generate billions to trillions of bases of high-quality DNA sequence per run. Cartridge-based reagent delivery and on-board cluster generation streamline the sample loading process and further reduce the likelihood of errors. Many reagents are shipped dry to reduce the need for dry ice and excess packaging. This spares the environment and makes unpacking and storage of reagents easier. NIH researchers use these platforms to investigate an ever-growing variety of genomics questions through approaches such as whole genome, exome, and transcriptome sequencing. These methods are valuable for diagnosing diseases, including very rare diseases, developing new therapeutic approaches for vaccination, understanding cancer progression, and predicting individual treatment plans, creating genome references for humans and microbes, and discovering new pathways of disease. For large-scale sequencers, much of the post-sequencing analysis can be completed directly on the sequencer at the end of a run. Illumina’s offering of instrument models gives individual investigators access to the technology at the benchtop and for larger projects, through centralized large-scale sequencing centers, such as NISC. All the sequencers accept libraries constructed in the same way and with the same reagents. The NIH also has numerous Illumina BeadArray-based Genotyping Systems that inform about copy number variation, gene expression, DNA methylation, in addition to genotypes.

Each Illumina instrument requires the use of reagents and consumables to ensure efficient operation and the desired outcomes of the operating systems. Reagents are chemicals and enzymes used to perform an assay or sequencing methodology. These include Library Preparation Kits, Cluster Kits, Enrichment Kits, Sequencing Kits, Custom Oligo Pools, Standard Oligo Pools, and Reagent Kits. Consumables are Arrays, Custom Arrays, Flow Cells, and accessories, which are used in the sequencing or genotyping process. All reagents and consumables must be compatible with, and optimally perform in the Illumina manufactured systems. The lllumina instruments require reagents and consumables to run the instruments and produce the required data. Reagents are critical to keeping the lllumina systems operating and can change frequently for various chemical/technical advances. As a result, the NIH requires the ability to select and purchase any reagent or consumable commercially available from the vendor’s catalog.

Purpose and Objectives:

The purpose of this procurement is to supply Illumina brand name reagents and consumables to the NIH community for use in the operation of NIH-owned and leased Illumina sequencing and genotyping systems that includes, 10 NovaSeq X Plus, 16 NovaSeq 6000, 49 NextSeq 1000/2000, 25 NextSeq 500/550, 66 MiSeq, 3 MiniSeq, 19 iSeq 100 and 13 iScan with a total of 201 Sequencing and Genotyping Systems. Each Illumina instrument requires the use of reagents and consumables to ensure efficient operation and the desired outcomes of the operating systems. Reagents are chemicals and enzymes used to perform an assay or sequencing methodology. These include Library Preparation Kits, Enrichment Kits, Sequencing Kits, Custom Oligo Pools, Standard Oligo Pools, and Reagent Kits. Consumables are Arrays, Custom Arrays, Flow Cells, and accessories, which are used in the sequencing or genotyping process. All reagents and consumables must be compatible with, and optimally perform in the Illumina manufactured systems. Reagents are critical to keeping the Illumina systems operating and can change frequently for various chemical/technical advances. If an equal reagent or consumable is proposed, it shall meet the same standards and produce the same results as the Illumina branded reagents and consumables.

Contractor Requirements:

· The contractor shall supply all reagents and consumables on an as needed basis as requested by delivery order to the National Institutes of Health’s Institutes and Centers’ delivery locations. A shipping schedule shall accompany the delivery order, with ship dates not to exceed 1 year from date of the delivery order. Requesters may make a limited number of adjustments to the shipping schedule after the order is placed.

· All reagents and consumables shall be compatible with and optimally perform in the applicable Illumina- based systems.

· The reagents and consumables shall support the installed and future set of Illumina Systems being utilized at the NIH and shall also provide for the following:

· Sequencing reagents must be able to produce up to 300 Mb (megabases) on small scale sequencers and up to 16,000 Gb of high-quality bases on high-throughput sequencers per run. Because of the rapid advances in this field, it is anticipated that run productivity will increase over time and reagents must be able to produce according to those advances.

· Sequencers must have reagents that support a broad range of data production (>16-fold) and read length (3-fold).

· Library preparation reagents must support a wide variety of applications, including RNA-Seq, single-cell RNA-Seq, whole genome, ChIP-Seq, ATAC-Seq, Hi-C, whole exome, miRNA, custom DNA/RNA enrichment panels, amplicons, targeted capture and long read whole genome.

· Library preparation reagents must have a minimum of 384 unique dual index adapters for PCR-free and RNA-Seq libraries.

· Library preparation reagents must be compatible with low input samples (≤25 ng) and with formalin fixed paraffin embedded (FFPE) damaged nucleic acids.

· Library preparation reagents must have simple protocols that can, with few exceptions, be completed in 1-2 days.

· Preparation time for getting libraries loaded onto sequencers should be less than one day.

· Sequencing reagents should be simple to prepare. They should include radio frequency identification (RFID) verification to eliminate incompatible loadings.

· At a minimum, large-scale sequencers will provide on-board base calling, variant detection for exomes and genomes, methylation analysis and gene expression analysis at no extra charge.

· Consumables, other than custom consumables, will conform to their specifications until the later of (i) 3 months from the date of shipment from Illumina, or (ii) any expiration date on the end of shelf-life pre-printed on such consumable by Illumina, but in either event, no later than 12 months from the date of shipment.

Anticipated Period of Performance:

September 3, 2025 - September 2, 2030

CONTRACTING WITHOUT PROVIDING FOR FULL OR OPEN COMPETITION (INCLUDING BRAND-NAME) DETERMINATION:

The determination by the Government to award a contract without providing for full and open competition is based upon the market research conducted as prescribed in FAR Part 10—Market Research, specifically the review and evaluation of the responses to the two sources sought notices published in the FedConnect and SAM.GOV on October 29, 2024. A Small Business Sources Sought Notice number 75N92025Q1127 and Other Than Small Business Sources Sought Notice number 75N92025Q1128 were posted in SAM.GOV and FedConnect. Both sources sought notices were titled, “Illumina Reagents and Consumables.”

This requirement is for the purchase of Illumina manufactured reagents and consumables for use in government owned, Illumina manufactured sequencing systems. Illumina was awarded the previous supply IDIQ contract by Other Than Full and Open Competition, specifically brand name only, pursuant to the acquisition authority set forth in FAR6.302-1-“Only responsible source and no other supplies or services will satisfy agency requirements and 41 U.S.C 253(c)(1). Illumina brand reagents and consumables are currently being used to run protocols on Illumina manufactured sequencing systems. All reagents and consumables are designed and produced specifically for use with the unique manufacturer’s sequencing system. The use of another manufacturer’s reagents and consumables in Illumina manufactured equipment would not guarantee the response or expected outcomes and would jeopardize the research results. Changing reagents and consumables would require the changing of sequencing systems which would negate the Government’s investment of millions of dollars of equipment and would jeopardize the research results already conducted. The use of Illumina reagents and consumables are required to replicate experimental procedures and protocols both published and in progress. The NIH must continue to purchase Illumina reagents and consumables in order to avoid the introduction of new variables into the experimental results and to avoid long delays resulting from retesting of products and sequencing systems. The Illumina reagents and consumables are proprietary to Illumina and are not manufactured by another source. There are no authorized 3rd party resellers.

CLOSING STATEMENT:

This synopsis is not a request for competitive proposals. However, interested parties may identify their interest and capability to respond to this notice. Responses to this notice shall contain sufficient information to establish the interested parties’ bona-fide capabilities for fulfilling the requirement and include the following: (1) the Unique Entity Identifier (UEI), the Taxpayer Identification Number (TIN), and the certification of business size; (2) information in sufficient details of the respondents’ staff expertise, including their availability, experience, and formal and other training; (3) current in-house capability and capacity to perform the work; (4) prior completed projects of similar nature; (5) corporate experience and management capability; and (6) examples of prior completed Government contracts, references, and other related information. All offerors must have an active registration in the System for Award Management (SAM) www.sam.gov

A determination by the Government not to compete this proposed contract based upon responses to this notice is solely within the discretion of the Government. The information received will normally be considered solely for the purposes of determining whether to proceed on a non-competitive basis or to conduct a competitive procurement.

This is not a Request for Proposal (RFP) and the Government is not committed to award a contract pursuant to this announcement. This advertisement does not commit the Government to award a contract.

THERE IS NO SOLICITATION AVAILABLE AT THIS TIME. However, should such a requirement materialize, no basis for claims against NHLBI shall arise as a result of a response to this notice or the NHLBI’s use of such information as either part of our evaluation process or in developing specifications for any subsequent requirement.

“Disclaimer and Important Notes. This notice does not obligate the Government to award a contract or otherwise pay for the information provided in response. The Government reserves the right to use information provided by respondents for any purpose deemed necessary and legally appropriate. Any organization responding to this notice should ensure that its response is complete and sufficiently detailed to allow the Government to determine the organization’s qualifications to perform the work.

Respondents are advised that the Government is under no obligation to acknowledge receipt of the information received or provide feedback to respondents with respect to any information submitted. After a review of the responses received, a solicitation may be published. However, responses to this notice will not be considered adequate responses to a solicitation.

Confidentiality. No proprietary, classified, confidential, or sensitive information should be included in your response. The Government reserves the right to use any non- proprietary technical information in any resultant solicitation(s).”

Submission Instructions:

All responses must be received by 12:00pm Eastern Time on 6 January 2025. Responses must be submitted via the SAM.GOV web portal ( https://sam.gov/) and also to both Points of Contact below via email Only:

Ethan Mueller Contracting Officer, ethan.mueller@nih.gov Dorothy Maxwell, Contract Specialist/Contracting Officer, maxwelld@nih.gov Potential Offerors do not need to register to view a notice; however, in order to submit questions and/or response to this Notice, an account will need to be established. Vendors can register with SAM.GOV at https://sam.gov/).

For assistance in registering or for other SAM.GOV technical questions please call the FedConnect Help Desk at (866)--606-8220, International calls: +1 334-206-7828 or email at https://www.fsd.gov/gsafsd_sp.

Please use the Contracting Officer/Contract Specialist contact information provided, should you require a waiver not to use FedConnect for submitting.

All responses must be received by the specified due date and time in order to be considered.

Confidentiality. No proprietary, classified, confidential, or sensitive information should be included in your response. The Government reserves the right to use any non-proprietary technical information in any resultant solicitation(s).”

Points of Contact:

Ethan Mueller Contracting Officer, ethan.mueller@nih.gov at (301) 496-2153, Department of Health and Human Services, National Institutes of Health, National Heart, Lung and Blood Institute, Office of Acquisitions, Bethesda, MD, 20892-7902, UNITED STATES.

Dorothy Maxwell, Contract Specialist/Contracting Officer, maxwelld@nih.gov at (301) 827-7729, Department of Health and Human Services, National Institutes of Health, National Heart, Lung and Blood Institute, Office of Acquisitions, Bethesda, MD, 20892-7902, UNITED STATES.

All responsible sources may submit a capability statement, proposal, or quotation, which shall be considered by the agency.